The purpose of this study is to conduct the initial clinical investigation of the HeartHill Medical's polymer aortic valve, namely PoliaVavle,to collect evidence on the device's safety and performance.
The polymer aortic valve, PoliaValve, from HeartHIll Medical, is indicated as a replacement for patients with severe aortic valve disease, including severe aortic stenosis, severe aortic regurgitation, or both. These patients will be included in the study after systematic assessment that the subjects meet the criteria for inclusion in the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Aortic Valve Replacement
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Compliance rate of prosthetic valve function
The compliance rate of prosthetic valve function evaluation at 1 month after surgery. The standard of prosthetic valve function is as follows: prosthetic valve pressure difference \<20mmHg or peak flow rate \< 3m/s, no moderate or above intravalvular regurgitation or paravalvular leakage), and no reintervention is required.
Time frame: 1 month following patient enrollment completion
Surgery success rate
Event-free survival of the prosthetic valve at 1 month postoperatively. Prosthetic valve degeneration includes stenosis and/or regurgitation due to structural abnormalities of the valve itself (e.g., leaflet tears, detachment, calcification, fibrosis, deformation of the valve frame, and fracture of the material of the connecting parts between the valve components) (referred to as structural valve degeneration), as well as dysfunction due to infective endocarditis, perivalvular leakage, valve prosthesis-patient mismatch, valve displacement, and leaflet thrombosis (referred to as nonstructural valve degeneration). Prosthetic valve degeneration usually consists of three stages, with the first stage consisting of morphological evidence of valve degeneration and structural abnormalities, before significant hemodynamic changes are evident.
Time frame: 1 month following patient enrollment completion
EOA
Use echocardiography to evaluate the effective valve orifice area(EOA) to assess the hemodynamic Performance.
Time frame: baseline and 1 month, 6months, 12months following patient enrollment completion
Mean transvalvular pressure difference
Use echocardiography to measure the mean transvalvular pressure difference.
Time frame: baseline and 1 month, 6months, 12months following patient enrollment completion
Peak flow velocity
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Use echocardiography to measure the peak flow velocity.
Time frame: baseline and 1 month, 6months, 12months following patient enrollment completion
Regurgitation
Evaluate the presence or absence of intravalvular or paravalvular regurgitation during the follow-up period by echocardiography.
Time frame: baseline and 1 month, 6months, 12months following patient enrollment completion
New York Heart Association Assessment (NYHA)
Evaluate New York Heart Association Assessment (NYHA) to see Heart Function Improvement.
Time frame: baseline and 1 month, 6months, 12months following patient enrollment completion
BNP or NT-proBNP
Measure BNP or NT-proBNP to get the changes in postoperative cardiac function from baseline.
Time frame: baseline and 1 month, 12months following patient enrollment completion